The particle sizes of various pharmaceuticals (drugs) and methods of their analysis and the quality requirements of drugs stated in regulations in terms of the Particle Size indicator are discussed. An analysis of the regulations showed that a general requirement for the standardization of the particle size of most dosage forms (DFs) is the absence of particles greater than 100 microns in size. Observed exceptions to the standard approach to standardization are presented. It should be considered that the quality requirements of drugs in terms of Particle Size are given in a General Pharmacopoeia Monograph (GPM) for each DF. The main method of optical microscopy is described in GPM 1.2.1.0009.15 Optical Microscopy of the State Pharmacopoeia of the Russian Federation (SP RF) and GPM 2.1.9.13 of the Pharmacopoeia of the Eurasian Economic Union (EAEU). Test results from recent years showed that 78.2% of drugs tested during pharmaceutical examination were DFs for local and external use, among which the percentage of non-compliance with the regulatory requirements was 1.3%.
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Acknowledgments
The work was performed in the framework of State Task for SCEEMP, Ministry of Health of Russia, No. 056-00001-22-01 for Performance of Applied Scientific Research (State Acct. No. NIR 121021800098-4).
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Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 57, No. 3, pp. 61 – 64, March, 2023.
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Gunar, O.V., Dorenskaya, A.V. Issues of Determining Particle Sizes of Various Drugs in Evaluating Their Quality. Pharm Chem J 57, 441–444 (2023). https://doi.org/10.1007/s11094-023-02902-4
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DOI: https://doi.org/10.1007/s11094-023-02902-4